FX Shoulder Prospective Clinical Study

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
FX Shoulder Solutions
Study ID
NCT06078865
Status
Recruiting

Conditions

  • Fracture, Shoulder
  • Osteoarthritis Shoulder
  • Rotator Cuff Syndrome of Shoulder and Allied Disorders

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • FX Artificial Shoulder Prosthesis — DEVICE
    Humelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System, Easytech Anatomical Shoulder System, FXV135 Mini Shoulder System, FXV135 Humelock Shoulder System

Study Details

Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.

Key Dates

Start date
Mar 31, 2021
Status verified
Feb 2026
Primary completion
Dec 30, 2031
Completion
Dec 30, 2031

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Subjects
    Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions

Primary Outcome Measure

A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS): [ Time Frame: 2 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
OrthoArizonaGilbertArizona85297
William Paterson, MD
480 284-4658
William Paterson, MD (PRINCIPAL_INVESTIGATOR)
First Settlement OrthopedicsMariettaOhio45750
Angie Miller, FNP-BC
740 373-8456
Joette Fetty, CPC
740 373-8756
John Henry, MD (PRINCIPAL_INVESTIGATOR)
Orthopedics Rhode IslandWakefieldRhode Island02879
Jennifer Stedman
401 777-7000
Michael Bradley, MD (PRINCIPAL_INVESTIGATOR)
Texas Orthopedic SpecialistsBedfordTexas76021
Amber Morgan
817.510.4022
Howard Harris, MD (PRINCIPAL_INVESTIGATOR)

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